FDA 510(k) Application Details - K131177

Device Classification Name	Irrigator, Sinus   More FDA Info for this Device
510(K) Number	K131177
Device Name	Irrigator, Sinus
Applicant	HEDGEPATH, LLC 324 S. HYDE PARK AVE. SUITE 350 TAMPA, FL 33606 US Other 510(k) Applications for this Company
Contact	FRANK E O'DONNELL, JR MD. Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	KAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2013
Decision Date	09/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review